This application relates to a flat-collapsible bag suitable for mixing one medicament or the like in aseptic and preferably sterile manner with another medicament.
For parenteral solution administration it is of course necessary to maintain the highest aseptic standards.
Particularly in the area of total parenteral nutrition, where a patient is completely maintained for significant periods of time by nutrients administered parenterally, there is a significant need for preserving sterility when the various nutrient solutions are mixed for administration. Specifically, when dextrose or other carbohydrate solutions are mixed with amino acid or protein hydrolyzate solutions, bacteria growth can be explosively rapid in the resulting mixture. So, particularly, care must be taken in such circumstances. On the other hand, it is of course clearly desirable to have a system which permits the safe mixing of parenteral solutions such as a dextrose or other carbohydrate solutions with an amino acid or protein hydrolyzate solution, while permitting the resulting mixture to be stored for a period of time.
Furthermore, once the connection between containers for mixing parenteral solutions is made, there is a need for a tamperproof seal to be provided, so that the connection between the containers may be broken and the emptied container discarded, while the container full of the mixed parenteral solution materials retains a reliable seal.
In a present system, a standard Viaflex.RTM. container, which is a flat, collapsible bag manufactured by Travenol Laboratories, Inc., is initially about half-filled with a parenteral solution such as 50% dextrose. Protein hydrolyzate solution may be administered into the Viaflex bag through the end spike of an administration set which passes through a diaphragm port of the Viaflex bag, which diaphragm port is carried by the peripheral heat seal of the bag.
After the protein hydrolyzate has passed through the set into the bag, filling it, the flexible tubing of the set may be conventionally sealed, and then cut so that the spike penetrating into the port of the Viaflex bag, and a sealed section of tubing connected to the spike, serves as a seal.
However, such a system is not tamperproof in that the spike can be removed from its port and then reinserted, which can cause a break of sterility and may institute the explosive growth of bacteria mentioned above. For example, upon refrigeration of the bag, the spike may shrink and loosen in the port, becoming more likely to slip out.
Also, if the spike is dislodged from its sealing position in the access port of the Viaflex bag, the contents of the bag can be spilled.
By this invention, a tamperproof system is provided for providing an aseptic communication port for a partially filled parenteral solution container for receiving a second parenteral solution for mixing. The improvement of this invention also provides a more easily handleable and manipulatable access port as well.